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NCT05519735Recruiting

Lymphatic Organs and Myocardium After Myocardial Infarction

Multimodal Characterization of Lymphatic Organs and Myocardium in Patients After Acute Myocardial Infarction

Source: ClinicalTrials.gov · Last updated 25 May 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The adaptive immune response plays an important role in myocardial healing and remodeling after acute myocardial infarction in patients. Therefore, the involved lymphocytes represent a novel target for therapeutic interventions. However, there are no established blood-derived biomarkers to predict the quantity and quality of the adaptive immune response to cardiac injury. Multimodal imaging of the heart and immunologic organs might provide such information. Recent retrospective analysis of patients after MI revealed enlarged mediastinal lymph nodes associated with increased CXCR4 radiotracer accumulation, thereby indicating that CXCR4 PET-based lymph node imaging provides a non-invasive quantitative readout of the local adaptive immune response. These considerations are further fuelled by the fact that, within lymph nodes, CXCR4 is expressed almost exclusively on lymphocytes, whereas various other cell types express CXCR4 within the myocardium. This leads to the hypothesis that the size of mediastinal lymph nodes and their respective CXCR4 PET signals correlate with the adaptive immune response to cardiac injury and might provide predictive information for functional cardiac decline during follow-up. This prospective clinical study will use multimodal imaging to monitor chemokine receptor 4 (CXCR4) expression in the lymph nodes, myocardium, spleen, and bone marrow after acute MI. The combination of cardiac magnetic resonance (CMR), echocardiography, and positron emission tomography (PET) along with blood collection for immunophenotyping will allow to determine i) if the size of mediastinal lymph nodes and their respective PET-derived CXCR4 signals at baseline correlate with the adaptive immune response to acute cardiac injury; and ii) if they predict cardiac adverse remodelling during longitudinal follow-up.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
57 (estimated)
First submitted
22 Aug 2022
Start date
1 Apr 2022
Primary completion date
Dec 2025
Lead sponsor
Wuerzburg University Hospital
NCT number
NCT05519735

What you commit to

  • Study type: Interventional
  • Planned participants: 57
  • From 1 Apr 2022 to the primary completion date, Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • immunosuppressive therapy

Other illness

  • known structural heart disease
  • multi vessel disease
  • acute inflammatory disease
  • active cardiac implants, ferromagnetic implants

Other

  • hemodynamic instablity \> 48 h after immediate catherization
  • known CAD
  • NSTEMI
  • sarcoidosis
  • no consent obtainable
  • contraindiations for CMR
  • impaired renal function
  • pregnancy, breast-feeding

Who the study is looking for

  • patients with acute myocardial infarction (STEMI) who were treated with immediate catheterization
  • stable clinical course
  • male/female, above 18 years old

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Wuerzburg
Coordinator of this site? Confirm its status
WürzburgGermanyRecruiting
Klinikum Würzburg Mitte, Medizinische Klinik
Coordinator of this site? Confirm its status
WürzburgGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.